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Dr. Lynne Jones: The Select Committee recommended that those who wished to challenge the patent should have the right to challenge it before it was considered by the relevant patenting organisation rather than have to wait until the patent had been granted and then challenge it in the courts, which would take many years. Will my hon. Friend look at that? The Committee wanted the Government to act.

Mr. Battle: Yes, I shall. I have only a few moments in which to reply and I feel constrained by the fact that this is not a full debate. We can consider that and I shall come to it in more detail in a moment.

We ought to remember that patents are available only for technical inventions. Rights cannot be obtained for finding something that freely occurs in nature, such as a gene sequence; nor can they be obtained for materials in their natural state. We should be absolutely clear that the human body and its elements in their natural state are not patentable. Moreover, treatments and diagnoses when performed on the human or animal body, including those using isolated genes, are not protectable. Plant and animal varieties also cannot be patented.

Furthermore, rights can be refused or revoked if it is found that using an invention would be immoral. As I said, given the promises of biotechnology for new treatments and cures, it seems that rather than providing patents on life, as some have suggested, one might see the system as providing patents for life.

Patents are obtained for new technical solutions to problems to the extent that an invention involves intervening in the genetic make-up, which in practice means that rights can encompass gene sequences, but only when separated from nature to the extent that the product of the invention is protectable. In other words, genes in their natural state cannot be patented, only new technical interventions. It is important to make that clear distinction.

As with any technology, those first in uncharted territory may be in a position to obtain patent rights that are broader than appear later to be justified once the area has been explored further. There has been concern that that may be happening in biotechnology--precisely the point that the hon. Gentleman raised. I must emphasise, however, that rights can always be challenged. That means that the judiciary should be ready to review the scope of the patentee's legal entitlement.

A recent case before the House of Lords--Biogenv. Medeva --has shown that monopolies can be cut back if they move into areas outside their legitimate scope. That case involved the ownership of a gene sequence relating, I think, to hepatitis B. As parts of that monopoly could not have been understood at the time, the court ruled against it. The courts can cut access to rights. Existing claims can be challenged and it is important to remember that.

I must say a few words about the European Commission's directive. It has a history--it was proposed as long ago as January last year. We managed to get the first opinion on the original proposal on 16 July. Some 70 amendments to the Commission's proposal were

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passed, including a suggestion from one Member of the European Parliament that an ethics committee should be created. We support that suggestion. We were asking the Commission to give us a proposal. That was the idea. There was nothing to discuss because the question had fallen into a void.

Essentially, the European Commission's proposal is a single market measure to extend or change the existing patent system in Britain. It is designed to enhance the operation of a single market in biotechnological products rather than to change the law in Britain.

The European Parliament's amendments were passed and we now need to study carefully the proposals that were put together from those amendments. We do not even have the final text of that document. When the proposals emerge, they will be put before us.

The European Commission is expected to amend its proposal in the light of the Parliament's opinion and to submit that to the Council of Ministers for adoption. Until

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the Commission's amended proposal emerges, it is not possible to determine the precise text that will be put before the Council of Ministers dealing with the internal market.

When the Council is able to reach a common position on the text, it will be sent back to the European Parliament, which will produce a second opinion. Only when the Council and Parliament have agreed will the directive be put forward for adoption in the member states. At that stage, we can discuss the statutory instrument in this Chamber and in Committee and there will be a full debate in the other place.

We are a long way from debating the detail. What we needed was a text to debate and that was the purpose of my letters, which were played off, one against another, rather unfairly.

The motion having been made after Ten o'clock, and the debate having continued for half an hour, Mr. Deputy Speaker adjourned the House without Question put, pursuant to the Standing Order.



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